Dynasplint Therapy for Trismus in Head and Neck Cancer

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT00507208
• Collaborator: Dynasplint Systems, Inc. (Industry)
• Enrollment: 53
• Location: 1
• Arms: 2
• Duration (Months): 96
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the use of the Dynasplint Trismus System to routine trismus treatment in improving the ability of opening the mouth in a randomized trial. This study will also determine what effects, good and/or bad, this procedure has on the participant. Participants will be randomly assigned to the Dynasplint Trismus System or to routine treatment with tongue depressors.

Condition or Disease	Intervention/Treatment	Phase
Trismus	Device: Dynasplint Trismus System; Other: Tongue Depressors	N/A

Detailed Description

This trial is a single-institution, randomized study to evaluate the effectiveness of the Dynasplint Trismus System (DTS) for patients with trismus. Improvement of mouth opening and quality of life of participants using DTS will be compared to improvement of mouth opening and quality of life of participants using standard therapy. Standard therapy will be the use of tongue depressors. Crossover from standard therapy to DTS will be implemented if at three months there is no improvement in mouth opening when using tongue depressors.

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Dynasplint Therapy for Trismus in Head and Neck Cancer
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dynasplint Participants randomized to this arm will be treated with the Dynasplint Trismus System	Device: Dynasplint Trismus System; The Dynasplint System will be used for 6 months.
Active Comparator: Control Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System	Other: Tongue Depressors; Tongue depressors to be used for 3 months at which time mouth opening will be measured. If there is no change then the patient will crossover to the Dynasplint Trismus System for another 3 months.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors [12 months]

   Number of participants who demonstrated improved maximal incisial opening (MIO), the distance from the tips of the upper and lower incisors on maximal effort. Successful improvement is defined as > 5mm improvement from the baseline measurement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients with <= 30mm mouth opening who have undergone treatment for head and neck cancer. (If the patient is edentulous then mouth opening must be <= 40mm.)

2. Patients who are receiving or have completed treatment for head and neck cancer (surgery, radiation, chemotherapy alone or in any combination).

3. Patients must be completely recovered from any radiation induced oral mucositis.

4. Age =>19 years.

5. Patients must sign informed consent.

Exclusion Criteria:

1. Severe periodontal or gum disease that has caused teeth to be loose.

2. Any systemic disease that causes blistering of the oral mucosa.

3. Any condition that renders the patient unable to understand the informed consent.

4. Participants who are not able to comply with protocol activities.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB Department of Otolaryngology	Birmingham	Alabama	United States	35233

Sponsors and Collaborators

• University of Alabama at Birmingham
• Dynasplint Systems, Inc.

Investigators

• Principal Investigator: William Carroll, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: William Carroll, MD, Professor of Otolaryngology, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT00507208
• Other Study ID Numbers: F070323014; HNO 0602
• First Posted: Jul 26, 2007
• Last Update Posted: Sep 13, 2016
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by William Carroll, MD, Professor of Otolaryngology, University of Alabama at Birmingham: trismus; head and neck cancer
• Additional relevant MeSH terms: Head and Neck Neoplasms; Trismus

Study Results

Participant Flow

Arm/Group Title	Dynasplint	Control
Arm/Group Description	Participants randomized to this arm will be treated with the Dynasplint Trismus System	Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
Period Title: Overall Study
STARTED	27	26
Received Dynasplint in Crossover	0	3
COMPLETED	27	26
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Dynasplint	Control	Total
Arm/Group Description	Participants randomized to this arm will be treated with the Dynasplint Trismus System	Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.	Total of all reporting groups
Overall Participants	27	26	53
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	24 88.9%	24 92.3%	48 90.6%
>=65 years	3 11.1%	2 7.7%	5 9.4%
Sex: Female, Male (Count of Participants)
Female	9 33.3%	6 23.1%	15 28.3%
Male	18 66.7%	20 76.9%	38 71.7%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	23 85.2%	17 65.4%	40 75.5%
African-American	3 11.1%	9 34.6%	12 22.6%
Hispanic	1 3.7%	0 0%	1 1.9%
Prior Treatment (participants) [Number]
Chemoradiation & Surgery	23 85.2%	22 84.6%	45 84.9%
Surgery only	4 14.8%	4 15.4%	8 15.1%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors
Description	Number of participants who demonstrated improved maximal incisial opening (MIO), the distance from the tips of the upper and lower incisors on maximal effort. Successful improvement is defined as > 5mm improvement from the baseline measurement.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dynasplint	Control
Arm/Group Description	Participants randomized to this arm will be treated with the Dynasplint Trismus System	Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
Measure Participants	27	26
MIO improvement > 5mm or more	12 44.4%	12 46.2%
MIO improvement < 5 mm or less	7 25.9%	7 26.9%
unknown MIO improvement	8 29.6%	7 26.9%

Adverse Events

Time Frame	1 year
Arm/Group Title	Dynasplint		Control
Arm/Group Description	Participants randomized to this arm will be treated with the Dynasplint Trismus System		Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
All Cause Mortality
	Dynasplint		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Dynasplint		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/27 (40.7%)		6/26 (23.1%)
Gastrointestinal disorders
oral fistula	1/27 (3.7%)		0/26 (0%)
esophageal stenosis	1/27 (3.7%)		1/26 (3.8%)
upper GI bleed	1/27 (3.7%)		0/26 (0%)
Infections and infestations
facial cellulitis	1/27 (3.7%)		0/26 (0%)
Injury, poisoning and procedural complications
injury to carotid artery	1/27 (3.7%)		0/26 (0%)
Metabolism and nutrition disorders
dehydration	1/27 (3.7%)		1/26 (3.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
disease recurrence resulting in death	2/27 (7.4%)		1/26 (3.8%)
Nervous system disorders
syncope	0/27 (0%)		1/26 (3.8%)
Respiratory, thoracic and mediastinal disorders
pneumonia	1/27 (3.7%)		1/26 (3.8%)
pharyngeal fistula	1/27 (3.7%)		0/26 (0%)
respiratory distress	1/27 (3.7%)		0/26 (0%)
pneumothorax	0/27 (0%)		1/26 (3.8%)
Surgical and medical procedures
debulking of scar tissue	1/27 (3.7%)		0/26 (0%)
mandibular debridement	1/27 (3.7%)		0/26 (0%)
planned procedures prior to radiation tx	0/27 (0%)		1/26 (3.8%)
Other (Not Including Serious) Adverse Events
	Dynasplint		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/27 (33.3%)		9/26 (34.6%)
Gastrointestinal disorders
oral pain	9/27 (33.3%)		9/26 (34.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.